Senior Quality and Compliance Specialist - Homebased, UK (GCP & CRO Experience)
About MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Job Specific Skills:
- Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
- Understanding of how to plan, prepare and conduct GCP audits independently.
- Proficient in authoring and managing audit documents independently.
- Develop CAPA plans and contribute to resolution of audit findings independently.
- Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
- Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
- Must be willing to travel up to 30% of the time for audits within the UK/EU.
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
- Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
- Expert knowledge of scientific principles and concepts.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Proficient with 21 CFR Part 11, FDA, and GxP requirements.
- Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
5+ years in a GCP-regulated industry, GCP audit experience, knowledge of FDA, GxP, and 21 CFR Part 11, audit documentation and CAPA skills, and proficiency with MS Office.
Key Responsibilities
- conducting GCP audits
- developing CAPA plans
- monitoring clinical sites
Skills & Tools
Microsoft Office, 21 CFR Part 11, FDA, GxP
Job Details
- Category: Quality Assurance
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — London, England, United Kingdom
- Languages: English
About MMS
A clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submissions. — Industry: Research and Development